In June 2012, Stryker, a medical technology company, decided to voluntarily recall its Rejuvenate and ABG II modular-neck hip stems. The modular neck-hip stems provide surgeons with the ability to correct certain aspects of a patient’s anatomy and his or her bio-mechanics. However they decided to recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction, which may result in ALTR (adverse local tissue reactions). In addition, possible pain and/or swelling at or around the hip may occur. This is due to metal-on-metal ball-and-socket components. Stryker’s two modular-neck hip stem systems do not consist of metal ball-and-sockets. However since the Stryker necks are made of chromium and cobalt and the stems are coated with titanium, they do have metal-on-metal connection. The friction caused by metal rubbing against metal deposits shards of metallic fragments into a patient’s tissues, bones or bloodstream. This is what causes the fretting, corrosion or swelling.
Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. However, both of the products were submitted under FDA’s 510(k) Premarket Notification Process. The process does not test the product if it is similar to one the FDA has already approved. Thus neither product was tested and both were approved because they were similar to other “sanctioned technologies.”
Approximately 20,000 Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012. Before the recall, Stryker acknowledged that the company was aware of the problems in an Urgent Field Safety notice sent to doctors in April 2012.
Stryker suggests that surgeons consider performing a clinical examination, such as blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling. Physicians should also perform a repeat follow-up examination, such as blood work. Cross section imaging should be considered even in the presence of normal initial findings, according to Stryker.
If you or a loved one is a patient who received Rejuvenate and ABG II modular-neck hip stems frequently asked questions for your physician are crucial in the follow up appointment. In addition Stryker is reimbursing patients for testing, treatment, revision surgery, and other costs relating to this voluntary recall, only if necessary. Questions on claims and reimbursement may assist you further. Stryker is partnering with Broadspire Services, Inc., immediately. This is a third-party claim that will help mange requests for reimbursements of costs relating to the voluntary recall.
If you or a loved one had one of these devices implanted and suffered from complications or side effects, you have the option to seek justice. You are not alone, while 20,000 other patients received the same procedure. Please feel free to give us a call for a free consultation.
Many of the orthopedic surgeons in the Dallas/Fort Worth area used the Stryker Rejuvenate and ABG II neck stems. Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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